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The Food and Drug Administration released new guidelines for coronavirus vaccine developers on Tuesday, a step that senior White House officials had delayed for two weeks. The guidelines make it highly unlikely that a vaccine will be licensed by Election Day.
The measure, which was approved by the White House Office of Management and Budget, appeared to be an abrupt change a day after The New York Times reported that White House officials, including Mark Meadows, the chief of staff, were blocking the guidelines. Senior FDA officials were surprised when they learned mid-afternoon that the new guidelines had been approved.
The new recommendations, which do not have the force of law, require the compilation safety data in the final stage of clinical trials before an emergency authorization can be granted.
On Tuesday night, President Trump showed his disgust at the action of his own White House, charging that the new guidelines were a conspiracy against his reelection prospects.
“The new FDA rules make it more difficult for them to expedite the approval of vaccines before Election Day. Yet another political success! ” he tweeted, labeling Dr. Stephen M. Hahn, the FDA commissioner.
The guidance was formally released hours after the FDA quietly posted the information at the end of a document prepared for an upcoming meeting of its vaccine advisory committee.
Since the start of the coronavirus pandemic, the FDA has said it has been looking for ways to accelerate vaccine development without sacrificing safety. In June, the agency published an initial set of guidelines to give vaccine developers a better idea of how the FDA would decide whether a vaccine was acceptable, either for an emergency use authorization or for a full license.
Four vaccines have reached the final stage of testing, known as a phase 3 trial, in the United States. A fifth is expected to start this month. Trump has repeatedly suggested that the vaccine would be ready by Election Day, if not earlier.
But with opinion polls showing a decline in public confidence about what a rushed coronavirus vaccine might be, the FDA submitted a new set of guidelines to the White House for approval on September 21, trying to ensure to companies that develop vaccines that are undergoing a common commitment. standard and increase public confidence in the process.
Among the recommendations, the agency advised vaccine manufacturers to follow volunteers for an average of two months after the final dose. The FDA also expected vaccine manufacturers to document five cases of serious infection in people who received the placebo instead of the vaccine.
The FDA submitted the guidelines to the Office of Management and Budget for approval more than two weeks ago, but they stalled in part because of Meadows’ involvement, according to a senior administration official and others familiar with the situation.
The White House objected that the guidelines would add unnecessary burdens on vaccine manufacturers. In a conversation with Dr. Hahn days after the guidelines were released, Meadows said the recommendations amounted to changing the rules on drug makers amid clinical trials, according to a senior administration official. It also suggested that Dr. Hahn was overly influenced by the career scientists who had written the paper, the official said.
Trump administration officials have the authority to intervene with such non-binding documents, in part because of a 2019 executive order that tightened restrictions on their issuance.
However, the FDA continued to share portions of this guide with vaccine developers in letters to companies.
“We made it clear that we want to see a median of about two months of follow-up for any of the incoming vaccines,” said Dr. Peter Marks, the FDA’s chief vaccine regulator, in an interview on YouTube. on Friday.
In a statement Tuesday, the pharmaceutical industry’s largest trade group, Pharmaceutical Research and Manufacturers of America, said it supported the new guidelines.
“We have engaged with the agency to provide support to bring greater transparency to the COVID-19 vaccine review process,” the statement said. “We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.”
Sharon LaFraniere contributed reporting from Washington.
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